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Circulation. 1998;98:2800-2804

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*Substance via MeSH
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*Genes and Gene Therapy

(Circulation. 1998;98:2800-2804.)
© 1998 American Heart Association, Inc.


Brief Rapid Communications

Gene Therapy for Myocardial Angiogenesis

Initial Clinical Results With Direct Myocardial Injection of phVEGF165 as Sole Therapy for Myocardial Ischemia

Douglas W. Losordo, MD; Peter R. Vale, MD; James F. Symes, MD; Cheryl H. Dunnington, MS; Darryl D. Esakof, MD; Michael Maysky, MD; Alan B. Ashare, MD; Kishor Lathi, MD; Jeffrey M. Isner, MD

From the Departments of Medicine, Biomedical Research, Surgery, and Anesthesiology, St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, Mass.

Correspondence to Jeffrey M. Isner, MD, St. Elizabeth's Medical Center, 736 Cambridge St., Boston, MA 02135.

Background—We initiated a phase 1 clinical study to determine the safety and bioactivity of direct myocardial gene transfer of vascular endothelial growth factor (VEGF) as sole therapy for patients with symptomatic myocardial ischemia.

Methods and Results—VEGF gene transfer (GTx) was performed in 5 patients (all male, ages 53 to 71) who had failed conventional therapy; these men had angina (determined by angiographically documented coronary artery disease). Naked plasmid DNA encoding VEGF (phVEGF165) was injected directly into the ischemic myocardium via a mini left anterior thoracotomy. Injections caused no changes in heart rate (pre-GTx=75±15/min versus post-GTx=80±16/min, P=NS), systolic BP (114±7 versus 118±7 mm Hg, P=NS), or diastolic BP (57±2 versus 59±2 mm Hg, P=NS). Ventricular arrhythmias were limited to single unifocal premature beats at the moment of injection. Serial ECGs showed no evidence of new myocardial infarction in any patient. Intraoperative blood loss was 0 to 50 cm3, and total chest tube drainage was 110 to 395 cm3. Postoperative cardiac output fell transiently but increased within 24 hours (preanesthesia=4.8±0.4 versus postanesthesia=4.1±0.3 versus 24 hours postoperative=6.3±0.8, P=0.02). Time to extubation after closure was 18.4±1.4 minutes; average postoperative hospital stay was 3.8 days. All patients had significant reduction in angina (nitroglycerin [NTG] use=53.9±10.0/wk pre-GTx versus 9.8±6.9/wk post-GTx, P<0.03). Postoperative left ventricular ejection fraction (LVEF) was either unchanged (n=3) or improved (n=2, mean increase in LVEF=5%). Objective evidence of reduced ischemia was documented using dobutamine single photon emission computed tomography (SPECT)-sestamibi imaging in all patients. Coronary angiography showed improved Rentrop score in 5 of 5 patients.

Conclusions—This initial experience with naked gene transfer as sole therapy for myocardial ischemia suggests that direct myocardial injection of naked plasmid DNA, via a minimally invasive chest wall incision, is safe and may lead to reduced symptoms and improved myocardial perfusion in selected patients with chronic myocardial ischemia.


Key Words: angiogenesis • ischemia • myocardium




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Cardiovasc ResHome page
K. Pels, C. Deiner, S. E Coupland, M. Noutsias, A. P Sutter, H.-P. Schultheiss, S. Yla-Herttuala, and P. L Schwimmbeck
Effect of adventitial VEGF165 gene transfer on vascular thickening after coronary artery balloon injury
Cardiovasc Res, December 1, 2003; 60(3): 664 - 672.
[Abstract] [Full Text] [PDF]


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CirculationHome page
K. Hiraoka, H. Koike, S. Yamamoto, N. Tomita, C. Yokoyama, T. Tanabe, T. Aikou, T. Ogihara, Y. Kaneda, and R. Morishita
Enhanced Therapeutic Angiogenesis by Cotransfection of Prostacyclin Synthase Gene or Optimization of Intramuscular Injection of Naked Plasmid DNA
Circulation, November 25, 2003; 108(21): 2689 - 2696.
[Abstract] [Full Text] [PDF]


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CirculationHome page
T. Namba, H. Koike, K. Murakami, M. Aoki, H. Makino, N. Hashiya, T. Ogihara, Y. Kaneda, M. Kohno, and R. Morishita
Angiogenesis Induced by Endothelial Nitric Oxide Synthase Gene Through Vascular Endothelial Growth Factor Expression in a Rat Hindlimb Ischemia Model
Circulation, November 4, 2003; 108(18): 2250 - 2257.
[Abstract] [Full Text] [PDF]


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J Am Coll CardiolHome page
F. J. Giordano
Retrograde coronary perfusion: a superior route to deliver therapeutics to the heart?
J. Am. Coll. Cardiol., September 17, 2003; 42(6): 1129 - 1131.
[Full Text] [PDF]


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Am. J. Physiol. Heart Circ. Physiol.Home page
T.-S. Li, K. Hamano, M. Nishida, M. Hayashi, H. Ito, A. Mikamo, and M. Matsuzaki
CD117+ stem cells play a key role in therapeutic angiogenesis induced by bone marrow cell implantation
Am J Physiol Heart Circ Physiol, August 7, 2003; 285(3): H931 - H937.
[Abstract] [Full Text] [PDF]


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Circ. Res.Home page
Y.-s. Yoon and D. W. Losordo
All in the Family: VEGF-B Joins the Ranks of Proangiogenic Cytokines
Circ. Res., July 25, 2003; 93(2): 87 - 90.
[Full Text] [PDF]


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CirculationHome page
M. Hedman, J. Hartikainen, M. Syvanne, J. Stjernvall, A. Hedman, A. Kivela, E. Vanninen, H. Mussalo, E. Kauppila, S. Simula, et al.
Safety and Feasibility of Catheter-Based Local Intracoronary Vascular Endothelial Growth Factor Gene Transfer in the Prevention of Postangioplasty and In-Stent Restenosis and in the Treatment of Chronic Myocardial Ischemia: Phase II Results of the Kuopio Angiogenesis Trial (KAT)
Circulation, June 3, 2003; 107(21): 2677 - 2683.
[Abstract] [Full Text] [PDF]


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CirculationHome page
S. Fleury, E. Simeoni, C. Zuppinger, N. Deglon, L. K. von Segesser, L. Kappenberger, and G. Vassalli
Multiply Attenuated, Self-Inactivating Lentiviral Vectors Efficiently Deliver and Express Genes for Extended Periods of Time in Adult Rat Cardiomyocytes In Vivo
Circulation, May 13, 2003; 107(18): 2375 - 2382.
[Abstract] [Full Text] [PDF]


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Ann. Thorac. Surg.Home page
I. Ahmet, Y. Sawa, T. Yamaguchi, and H. Matsuda
Gene transfer of hepatocyte growth factor improves angiogenesis and function of chronic ischemic myocardium in canine heart
Ann. Thorac. Surg., April 1, 2003; 75(4): 1283 - 1287.
[Abstract] [Full Text] [PDF]


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CirculationHome page
N. Tomita, R. Morishita, Y. Taniyama, H. Koike, M. Aoki, H. Shimizu, K. Matsumoto, T. Nakamura, Y. Kaneda, and T. Ogihara
Angiogenic Property of Hepatocyte Growth Factor Is Dependent on Upregulation of Essential Transcription Factor for Angiogenesis, ets-1
Circulation, March 18, 2003; 107(10): 1411 - 1417.
[Abstract] [Full Text] [PDF]


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Ann. Thorac. Surg.Home page
M. Nishida, T.-S. Li, K. Hirata, M. Yano, M. Matsuzaki, and K. Hamano
Improvement of cardiac function by bone marrow cell implantation in a rat hypoperfusion heart model
Ann. Thorac. Surg., March 1, 2003; 75(3): 768 - 773.
[Abstract] [Full Text] [PDF]


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Ann. Thorac. Surg.Home page
F. W. Sellke and M. Ruel
Vascular growth factors and angiogenesis in cardiac surgery
Ann. Thorac. Surg., February 1, 2003; 75(2): S685 - 690.
[Abstract] [Full Text] [PDF]


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Card Surg AdultHome page
M. Ruel, R. A. Kelly, and F. W. Sellke
Therapeutic Angiogenesis, Transmyocardial Laser Revascularization, and Cell Therapy
Card. Surg. Adult, January 1, 2003; 2(2003): 715 - 750.
[Full Text]


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CirculationHome page
D. W. Losordo and A. Kawamoto
Biological Revascularization and the Interventional Molecular Cardiologist: Bypass for the Next Generation
Circulation, December 10, 2002; 106(24): 3002 - 3005.
[Full Text] [PDF]


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Physiol. GenomicsHome page
T. H. Kim, K. A. Skelding, E. G. Nabel, and R. D. Simari
What can cardiovascular gene transfer learn from genomics: and vice versa?
Physiol Genomics, December 3, 2002; 11(3): 179 - 182.
[Abstract] [Full Text] [PDF]


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J. Pharmacol. Exp. Ther.Home page
J.-S. Silvestre, N. Kamsu-Kom, M. Clergue, M. Duriez, and B. I. Levy
Very-Low-Dose Combination of the Angiotensin-Converting Enzyme Inhibitor Perindopril and the Diuretic Indapamide Induces an Early and Sustained Increase in Neovascularization in Rat Ischemic Legs
J. Pharmacol. Exp. Ther., December 1, 2002; 303(3): 1038 - 1043.
[Abstract] [Full Text] [PDF]


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J. Thorac. Cardiovasc. Surg.Home page
T. Funatsu, Y. Sawa, S. Ohtake, T. Takahashi, G. Matsumiya, N. Matsuura, T. Nakamura, and H. Matsuda
Therapeutic angiogenesis in the ischemic canine heart induced by myocardial injection of naked complementary DNA plasmid encoding hepatocyte growth factor
J. Thorac. Cardiovasc. Surg., December 1, 2002; 124(6): 1099 - 1105.
[Abstract] [Full Text]


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Eur Heart JHome page
A. Tandar, G.M. Saperia, and D.H. Spodick
Direct myocardial revascularization and therapeutic angiogenesis
Eur. Heart J., October 1, 2002; 23(19): 1492 - 1502.
[Full Text] [PDF]


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CirculationHome page
M. C. Cid, J. Hernandez-Rodriguez, M.-J. Esteban, M. Cebrian, Y. S. Gho, C. Font, A. Urbano-Marquez, J. M. Grau, and H. K. Kleinman
Tissue and Serum Angiogenic Activity Is Associated With Low Prevalence of Ischemic Complications in Patients With Giant-Cell Arteritis
Circulation, September 24, 2002; 106(13): 1664 - 1671.
[Abstract] [Full Text] [PDF]


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CirculationHome page
M. Ono, Y. Sawa, K. Matsumoto, T. Nakamura, Y. Kaneda, and H. Matsuda
In Vivo Gene Transfection With Hepatocyte Growth Factor via the Pulmonary Artery Induces Angiogenesis in the Rat Lung
Circulation, September 24, 2002; 106(12_suppl_1): I-264 - I-269.
[Abstract] [Full Text] [PDF]


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J. Appl. Physiol.Home page
Y. Yang, J.-Y. Min, J. S. Rana, Q. Ke, J. Cai, Y. Chen, J. P. Morgan, and Y.-F. Xiao
VEGF enhances functional improvement of postinfarcted hearts by transplantation of ESC-differentiated cells
J Appl Physiol, September 1, 2002; 93(3): 1140 - 1151.
[Abstract] [Full Text] [PDF]


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Am. J. Physiol. Heart Circ. Physiol.Home page
T.-S. Li, K. Hamano, K. Suzuki, H. Ito, N. Zempo, and M. Matsuzaki
Improved angiogenic potency by implantation of ex vivo hypoxia prestimulated bone marrow cells in rats
Am J Physiol Heart Circ Physiol, August 1, 2002; 283(2): H468 - H473.
[Abstract] [Full Text] [PDF]


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Proc. Natl. Acad. Sci. USAHome page
H. Su, J. Arakawa-Hoyt, and Y. W. Kan
Adeno-associated viral vector-mediated hypoxia response element-regulated gene expression in mouse ischemic heart model
PNAS, July 9, 2002; 99(14): 9480 - 9485.
[Abstract] [Full Text] [PDF]


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HypertensionHome page
Y. Taniyama, R. Morishita, M. Aoki, K. Hiraoka, K. Yamasaki, N. Hashiya, K. Matsumoto, T. Nakamura, Y. Kaneda, and T. Ogihara
Angiogenesis and Antifibrotic Action by Hepatocyte Growth Factor in Cardiomyopathy
Hypertension, July 1, 2002; 40(1): 47 - 53.
[Abstract] [Full Text] [PDF]


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J Am Coll CardiolHome page
H. Franz Alber, J. Dulak, M. Frick, W. Dichtl, S. Paul Schwarzacher, O. Pachinger, and F. Weidinger
Atorvastatin decreases vascular endothelial growth factor in patients with coronary artery disease
J. Am. Coll. Cardiol., June 19, 2002; 39(12): 1951 - 1955.
[Abstract] [Full Text] [PDF]


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J. Thorac. Cardiovasc. Surg.Home page
E. Leotta, G. Patejunas, G. Murphy, J. Szokol, L. McGregor, J. Carbray, A. Hamawy, D. Winchester, N. Hackett, R. Crystal, et al.
Gene therapy with adenovirus-mediated myocardial transfer of vascular endothelial growth factor 121 improves cardiac performance in a pacing model of congestive heart failure
J. Thorac. Cardiovasc. Surg., June 1, 2002; 123(6): 1101 - 1113.
[Abstract] [Full Text] [PDF]


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HypertensionHome page
S.-i. Yoshimura, R. Morishita, K. Hayashi, J. Kokuzawa, M. Aoki, K. Matsumoto, T. Nakamura, T. Ogihara, N. Sakai, and Y. Kaneda
Gene Transfer of Hepatocyte Growth Factor to Subarachnoid Space in Cerebral Hypoperfusion Model
Hypertension, May 1, 2002; 39(5): 1028 - 1034.
[Abstract] [Full Text] [PDF]


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Ann. Thorac. Surg.Home page
K. Hamano, T.-S. Li, T. Kobayashi, K. Hirata, M. Yano, M. Kohno, and M. Matsuzaki
Therapeutic angiogenesis induced by local autologous bone marrow cell implantation
Ann. Thorac. Surg., April 1, 2002; 73(4): 1210 - 1215.
[Abstract] [Full Text] [PDF]


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J Am Coll CardiolHome page
M. C. Kim, A. Kini, and S. K. Sharma
Refractory angina pectoris: Mechanism and therapeutic options
J. Am. Coll. Cardiol., March 20, 2002; 39(6): 923 - 934.
[Abstract] [Full Text] [PDF]


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CirculationHome page
C. L. Grines, M. W. Watkins, G. Helmer, W. Penny, J. Brinker, J. D. Marmur, A. West, J. J. Rade, P. Marrott, H. K. Hammond, et al.
Angiogenic Gene Therapy (AGENT) Trial in Patients With Stable Angina Pectoris
Circulation, March 19, 2002; 105(11): 1291 - 1297.
[Abstract] [Full Text] [PDF]


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Ann. Thorac. Surg.Home page
M.-H. Liu, H. Jin, H. S. Floten, Z. Ren, A. P.C. Yim, and G.-W. He
Vascular endothelial growth factor-mediated, endothelium-dependent relaxation in human internal mammary artery
Ann. Thorac. Surg., March 1, 2002; 73(3): 819 - 824.
[Abstract] [Full Text] [PDF]


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J. Pharmacol. Exp. Ther.Home page
A. Scherpereel, J. J. Rome, R. Wiewrodt, S. C. Watkins, D. W. Harshaw, S. Alder, M. Christofidou-Solomidou, E. Haut, J.-C. Murciano, M. Nakada, et al.
Platelet-Endothelial Cell Adhesion Molecule-1-Directed Immunotargeting to Cardiopulmonary Vasculature
J. Pharmacol. Exp. Ther., March 1, 2002; 300(3): 777 - 786.
[Abstract] [Full Text] [PDF]


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HeartHome page
J M Cotton, M R Thomas, B J Dunmore, J Salisbury, A M Shah, and N P J Brindle
Angiogenesis in chronically ischaemic human heart following percutaneous myocardial revascularisation
Heart, March 1, 2002; 87(3): 281 - 283.
[Full Text] [PDF]


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Cardiovasc ResHome page
M. Shimpo, U. Ikeda, Y. Maeda, M. Takahashi, H. Miyashita, H. Mizukami, M. Urabe, A. Kume, T. Takizawa, M. Shibuya, et al.
AAV-mediated VEGF gene transfer into skeletal muscle stimulates angiogenesis and improves blood flow in a rat hindlimb ischemia model
Cardiovasc Res, March 1, 2002; 53(4): 993 - 1001.
[Abstract] [Full Text] [PDF]


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HeartHome page
H El-Gendi, A G Violaris, R Foale, H S Sharma, and D J Sheridan
Endogenous, local, vascular endothelial growth factor production in patients with chronic total coronary artery occlusions: further evidence for its role in angiogenesis
Heart, February 1, 2002; 87(2): 158 - 159.
[Full Text] [PDF]


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CirculationHome page
J. Rockstroh and B. G. Brown
Coronary Collateral Size, Flow Capacity, and Growth: Estimates From the Angiogram in Patients With Obstructive Coronary Disease
Circulation, January 15, 2002; 105(2): 168 - 173.
[Abstract] [Full Text] [PDF]


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Cold Spring Harb Symp Quant BiolHome page
J.A. NAGY, E. VASILE, D. FENG, C. SUNDBERG, L.F. BROWN, E.J. MANSEAU, A.M. DVORAK, and H.F. DVORAK
VEGF-A Induces Angiogenesis, Arteriogenesis, Lymphangiogenesis, and Vascular Malformations
Cold Spring Harb Symp Quant Biol, January 1, 2002; 67(0): 227 - 238.
[Abstract] [PDF]